Effects of Dietary Polyphenols and ω-3 Fatty Acids on Cardiovascular Risk Factors in High Risk Subjects (Etherpaths)

Federico II University

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Other: Diet rich in polyphenols; Other: Control diet; Other: diet rich in omega-3 and polyphenols; Other: Diet rich in omega-3 fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT01154478

EpWP5

Details and patient eligibility

About

The aim of this study is to explore if a 8-weeks dietary intervention with polyphenols and omega 3 fatty acids (alone or combined) may be effective on postprandial lipids metabolism and other cardiovascular risk factors in people at high cardiovascular risk.

Full description

Fish consumption is associated with a lower cardiovascular risk and dietary supplementation with ω-3 fatty acids reduces plasma triglyceride levels. The mechanisms of action of ω-3 fatty acids are currently not completely understood. It has been hypothesized that polyunsaturated ω-3 fatty acids beneficial effects may be mediated through their ability to facilitate plasmalogen replenishment.

Polyphenols are associated with beneficial effects on some cardiovascular risk factors, in particular with a reduced lipid oxidation. Less data are available on their effects on lipid metabolism. Recent data suggest that these effects could be mediated by changes in plasmalogen levels.

The effects on lipid metabolism of combining the two dietary approaches (ω-3 fatty acids and polyphenols) are not known.

While developed populations live for the most part in the postprandial state, much of the information on lipid metabolism refers to fasting condition.

Dietary Intervention Study Design

Eighty people at high cardiovascular risk randomly assigned to one of the four different nutritional 8-week interventions:

(A) Control diet poor in omega-3 fatty acids and polyphenols (B) Diet rich in omega-3 fatty acids (C) Diet rich in polyphenols (D) Diet rich in omega-3 fatty acids and polyphenols

Enrollment: 86 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• bmi >25<35 kg/m2
• High waist circumference (men >102 cm, women >88 cm) + one the following components of metabolic syndrome :

Fasting plasma triglycerides ≥150 mg/dl Fasting HDL-col <40 mg/dl (men) and <50 mg/dl (women) Fasting plasma glucose 100-125 mg/dl

Exclusion criteria

• Fasting plasma triglycerides ≥400 mg/dl and cholesterol >270 mg/dl
• Cardiovascular events (AMI and/or stroke) in the last 6 months
• Diabetes mellitus
• Regular intensive physical activity
• Kidney (serum creatinine >1.7 mg/dl) and liver (transaminases >double)
• Hypolipidemic or antinflammatory drugs
• Anemia (Hb <12 g/dl) or any other chronic disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 4 patient groups, including a placebo group

B group

Experimental group

Description:

Diet rich in omega-3 fatty acids

Treatment:

Other: Diet rich in omega-3 fatty acids

C group

Experimental group

Description:

Diet rich in polyphenols

Treatment:

Other: Diet rich in polyphenols

D group

Experimental group

Description:

Diet rich in polyphenols and in omega-3 fatty acids

Treatment:

Other: diet rich in omega-3 and polyphenols

A group (control group)

Placebo Comparator group

Description:

diet with low content of omega-3 fatty acids and polyphenols

Treatment:

Other: Control diet